An Intermediate Access Protocol for Selumetinib for Treatment of Neurofibromatosis Type 1 With Inoperable Progressive/Symptomatic Plexiform Neurofibromas (PN)

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Updated on 19 February 2024

Summary

The purpose of this study is to provide compassionate access to selumetinib capsules to patients for the treatment of NF1.

Description

This will be an open-label, single-arm, multicenter intermediate access protocol which provides treatment access to selumetinib for eligible patients with neurofibromatosis type 1 (NF1) who have inoperable, progressive/symptomatic plexiform neurofibromas (PN) without any alternative therapeutic options. All patients will continue to receive drug while they are deriving clinical benefit . Approximately 100 patients in the US will be treated as part of this protocol.

Participants will not be paid for their participation.

FAQ

Participants will not be paid for their participation.

Details
Condition neurofibromatosis,neurofibroma,neurofibromas,plexiform neurofibroma,PN
Age 2years - 100years
Clinical Study IdentifierTX7986
Last Modified on19 February 2024

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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